This invention relates to medico-surgical collection bag assemblies.
The invention is more particularly concerned with two-part ostomy bag assemblies and the like, having a bag that is removable from a fitment attached to the user's skin around a stoma or other discharge outlet.
Ostomy bags are used to collect fecal matter discharged from a surgically made stoma in the patient's abdomen. In one form of bag, the opening to the bag is provided with an adhesive ring which is used to secure the bag directly to the patient's skin around the stoma. The two-part ostomy bag assembly differs from this in that a fitment is adhered to the user's skin; the bag is a separate component, being coupled to the patient fitment in a releasable manner, usually by means of a relatively rigid coupling member on the bag. The bag is removed and disposed of when necessary by uncoupling from the fitment which remains in place to receive a new bag. The fitment can remain in place for several days before it also needs to be removed. Various forms of two-part assemblies have been proposed. These generally include mating rigid or semi-rigid coupling rings on the bag and fitment. Examples of such bag assemblies are described in EP0259184A, EP 0270400A, EP 0213721A, U.S. Pat. No. 4,775,374, GB 1455784, GB 1217406, GB 1568860, GB 1571986, GB 1579875, GB 1583027, GB2115288A, GB 2147810A, GB 2148120A, GB 2148716A, GB 2153683A, GB 2158719A, GB 2163350A, GB 2163959A, GB 2172204A, GB 2173403A, GB 2179556A, GB 2183481A, GB 2190841A, GB 2193097A, GB 2193098A, GB 2193439A, GB 2193893A, GB 2196257A, GB 2198953A, GB 2198954A, GB 2201345A, GB 2201346, GB 2201347A, GB 2205041A, GB 2206801A GB 2215212A. These forms of assembly suffer from various disadvantages since they are either difficult for the patient to use, or cause discomfort during coupling or uncoupling. The difficulty of coupling and uncoupling previous assemblies can sometimes disturb the seal of the body-worn fitment with the skin and lead to leakage. The coupling rings also mean that the assemblies are relatively bulky and obtrusive and may not flex with movement of the anatomy, leading to discomfort.
It has been proposed in GB 2225956A, to have a patient fitment with a planar front surface and to secure the bag to the fitment by means of an adhesive flange on the bag. A somewhat similar bag assembly is also sold by Eschmann Bros. & Walsh Limited under the trade mark Beta. Such assemblies have several advantages in that they can have very low profiles making them unobtrusive. They can be coupled and uncoupled easily without discomfort. They also lend themselves to use with w.c. disposable bags because the bag lacks any rigid coupling ring which could provide an obstruction to flushing. The difficulty with assemblies of these kinds is that, although they will provide a secure attachment to a flat surface, where the patient is fatter and the stoma is located on a convex part of the anatomy, there can be a tendency for a patient fitment to peel away from the skin, especially as the bag fills and becomes heavier. The problem is aggravated if the patient has skin folds in the region of the stoma. This problem could be reduced by making the patient fitment more flexible so that it conforms more readily to the anatomy but the problem is then transferred to the adhesive connection of the bag to the patient fitment, increasing the tendency of the patient fitment to separate from the bag. Where the patient fitment is flexible, it may wrinkle, especially with movement of the patient, making secure attachment to the patient fitment unreliable.